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The Clinical Efficacy of Belting Stabilization for Shoulder Pain

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Helen Razmjou, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00826293
First received: January 20, 2009
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  Purpose

Application of a belt for stabilization while exercising accelerate and optimize recovery in patients diagnosed with shoulder impingement syndrome.


Condition Intervention Phase
Rotator Cuff Impingement Syndrome
 Procedure: Stabilization belt
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Efficacy of Belting Stabilization for Shoulder Pain: A Double Blinded Randomized Clinical Trial

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • The Primary outcome measure is a subjective measure, the Quick Disability of the Arm, Shoulder and Hand (QuickDASH) [ Time Frame: Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary subjective outcomes include a joint specific measure, the American shoulder and Elbow Surgeons (ASES) score, and the work limitation questionnaire (WLQ-25). [ Time Frame: Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: January 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: True Stabilization Group
Patients will be randomized to one of the two treatment groups (true stabilization vs. sham stabilization). Patients will be exercising with a belt that is expected to reduce impingement of the rotator cuff tendons.
 Procedure: Stabilization belt
Patients receive true stabilization.
Other Name: Belt Stabilization
Sham Comparator: Sham Stabilization
Patients receive sham stabilization. The sham procedure imitates the treatment without any true effect.
 Procedure: Stabilization belt
Patients receive sham stabilization.
Other Name: Ineffective stabilization

Detailed Description:

Stabilization through belts is commonly used as an adjunct for treatment of musculoskeletal problems. Although this treatment is popular among clinicians, there is a paucity of evidence on its use for shoulder pathology. The objective of this double-blinded longitudinal randomized controlled trial (RCT) is to determine the clinical efficacy of stabilization belting applied to patients receiving rehabilitation treatment for shoulder impingement syndrome. The study population will include patients who have been referred to the physiotherapy department of the Holland Orthopaedic & Arthritic Centre for conservative treatment. Patients will be randomized into the treatment and control groups. The primary outcome measure is the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of impingement syndrome or post-surgical stiffness with an abnormal scapulothoracic rhythm

Exclusion Criteria:

  • Inability to speak or read English
  • Evidence of major joint trauma causing fracture
  • Infection
  • Underlying metabolic or inflammatory disease
  • Avascular necrosis
  • Frozen shoulder
  • Major medical illness
  • Psychiatric illness that precluded informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826293

Locations
Canada, Ontario
Holland Orthopaedic and Arthritic Centre
Toronto, Ontario, Canada, M4Y 1H1
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Helen Razmjou, PhD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Helen Razmjou, Dr. Helen Razmjou, Physical Therapist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00826293     History of Changes
Other Study ID Numbers: 224-2008
Study First Received: January 20, 2009
Last Updated: February 16, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
 Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013